The Case for Technoshpere Insulin
Mannkind, on the other hand, is wagering on Technosphere Insulin. The company believes that the technology improves the odds of quicker and more efficacious insulin delivery. The Technosphere platform stabilizes insulin into its monomeric form before release, which the body can readily use, explains Richard Anderson, corporate vp—office of the chairman. Insulin usually exists as a hexamer and must first be broken down into three dimers and finally individual molecules to have a physiological effect.
Current insulin analogs are designed to be hexamers that dissociate more quickly than regular insulin. When the Technosphere Insulin particles dissolve in the deep lung, however, the released insulin is already a mixture of dimers and monomers.
The fast kinetics of Technosphere Insulin is the main difference between this product and other inhaled insulin products that were in development, Anderson points out. “Several studies have shown that unlike others working in inhaled insulin who did find impaired lung function post treatment, we saw no change of lung function in our Technosphere Insulin treatment group compared to the group on standard of care.
“The second advantage is that patients who take insulin have been observed to gain weight,” Anderson continues. Study participants in Mannkind’s trials did not gain weight, he reports.
Additionally, preclinical evaluations including a two-year carcinogenicity study in rats showed that Technosphere Insulin was well tolerated with no indications of carcinogenic potential or cellular proliferation in the lungs.
Anderson is confident that Phase III data will be positive and show good efficacy. “There are currently four Phase III trials under way, three of which are pivotal.” He expects results from two in the third quarter and data from the remaining studies by year end, which is when Mannkind anticipates filing an NDA.
“Two-thirds of patients do not reach their glucose targets. If we can demonstrate significantly improved glucose control at meal time, that would certainly show an advantage.”